For Validation services in the Project Engineeirng/Medical Device Packaging area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Engineering and at least four (4) years of exposure to Validation Engineering activities within the Pharmaceutical or Medical Devices industry. ,
• Bilingual (Spanish and English)
• Shift: Administrative & according to business needs 
• Experience in:
  • Packaging validation and testing activities for sterile and non-sterile medical device packaging systems.
  • Engineering documentation, data collection, technical reports, protocols, specifications, and change records.
  • Manufacturing processes, engineering concepts, and problem-solving methodologies.
  • FDA QSR, ISO 13485, ISO 9001, GMP environments, MDR, and CMDR requirements (preferred).
  • Validation activities, laboratory testing, statistical analysis, and risk assessments (preferred).
  • Medical device packaging systems, sterile barrier systems, and validation methodologies (preferred). 

The Personality Part:    

• Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Support packaging validation and testing activities for sterile and non-sterile medical device packaging systems. 
• Assist senior engineers in the execution of packaging studies, validation protocols, engineering evaluations, and testing activities.
• Collect, organize, analyze, and document testing data to support validation efforts and engineering decision-making.
• Support engineering activities including setup, sample preparation, data collection, and documentation tasks.
• Prepare and maintain technical documentation such as protocols, reports, test summaries, specifications, and change records.
• Coordinate activities with cross-functional teams including Quality, Operations, Regulatory Affairs, and Product Development.
• Support troubleshooting efforts related to packaging performance, manufacturing processes, or testing issues.
• Assist with risk assessments, continuous improvement initiatives, and process optimization projects.
• Ensure compliance with internal procedures and applicable regulatory requirements including FDA QSR, ISO 13485, ISO 9001, MDR, and CMDR.
• Maintain accurate project records and support the timely completion of assigned deliverables.
• Participate in packaging line trials, validation builds, and manufacturing support activities.
• Provide on-site support across different shifts and weekends as required by project and operational needs.
• Demonstrate initiative, accountability, flexibility, and willingness to learn new technical skills and regulatory requirements.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! 

Are you the Next Piece?